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I agree, getting a handle on Anchor market potential is extremely difficult. I think Lovaza has been very aggressive off label and very successful at getting some insurance coverage off label, I'm not sure insurance companies were paying much attention until last year on off label payment, just paying the tier 2 for the drug. Based on old posts the reps were selling off label from day 1.
But Lovaza IS limited on what they can say and what they can advertise so off label useage, you would think, would be a fraction of potential market.
Many High Trig people will look to exercise and other OTC options before going for a prescription so the percent of high trig population getting a prescription should be less than the percent of Very High trig population.
But what the real available market is in Anchor is really a wide range. There are few scenarios where it would not lead to a stock price 15 or higher but what that # is and how fast they penetrate the market determines if upside is 15 or 50. Just seems to be no way to get a good handle on that.
Great drug overall but there is a reason it is in the 5's
Most people are not spending that much time analyzing the details between Vascepa and Lovaza and fish oil.
One of my other issues is what is the real market size for Vascepa? If 70% of Lovaza is off-label then 700 million of sales are Anchor and 300 million are Marine so not sure what the Marine market really is. If it's only 300 million then Anchor is only 3 Billion(times 10) and the peak sales(non REDUCE IT outcome) are near 2 billion which still makes it undervalued but not a 10 billion dollar market.
I know they(Lovaza) cannot sell to Anchor full bore due to the off label restrictions but based on the number of people in High trig it seems a small percentage are on Lovaza or Vascepa.
Vascepa should expand Anchor indication due to easier insurance reimbursement, easier for more doctors to prescribe off label but education will be huge when comes to replacing the standard PCP "Take fish oil" with them saying they will prescribe Vascepa. I do not see how AMRN in any GIA type scenario can do that with Anchor. Which is why I was happy when JZ said no GIA for Anchor and seems heavy leaning toward partnership.
I also liked the fact ELAN mentioned positive things about AMRN as they absolutely 100% have to partner for Anchor and knowing there is at least one publicly interested party means they should be able to get some kind of deal done.
If they can get a deal that pays off the debt and gives incentive to both parties to grow Vascepa it's a win even if they give up 25% of sales.
The August CC will be interesting, JZ needs to continue the we will not GIA on Anchor that he had at the last CC, any change in that stance would be bad.
They do the deal right and the stock is at 15 and then bought out a year later, they do the deal wrong and we will be waiting another 6 months to a year to see if they can sell Anchor properly as stock price languishes.
It's July 4th week, many people take vacation, volume will be low all week(really, really low on Thursday HA)
It'll hover between 5.50 and 6.00 through this week and we'll see if anything comes out of shareholder meeting next week or OB update after that.
A little harsh on your HDL, it went down 1 point which is insignificant which matches the Marine and Anchor studies.
Above 40 is still OK and the LDL/HDL ratio is good so that's some good progress.
There are several ways to increase HDL though my favorite is clearly:
One or two alcoholic drinks per day can significantly increase HDL levels. FYI-More than one or two drinks per day is BAD.
I don't see how it(the ratio) can't do anything but go up, refills are like compound interest and as Joe stated they are through 75% of Cardiologists 4-5 times where maximum new scripts get written. New scripts are going to be up and down with a small trend up as they reach the final cardiologists, expand a bit to PC,P and people complete their annual visits with cardiologists and I imagine some of those see the cardiologist more often as they are higher risk.
Logic just dictates Refills will go up exponentially to new scripts, not sure how anybody could think otherwise
Pfizer is just re-upping the previous 10 billion buyback from Dec 2011, there net income per year is more than that and the 10 billion based on the last 10 billion will be spread over at least the next 2 years, they still have more than that in net income per year, a large cash hoard balance sheet.
Since they did the same thing for the exact same amount in Dec 2011 I don't now how it relates to AMRN, if anything it's surprising the amount was the same with the Zoetis spin off being accretive to 2014 earnings they could have bumped the buyback to 11 or 12 billion.
This has zero effect on AMRN, if anything a mild positive because they did not increase the share repurchase amount from last time meaning they are keeping more cash on hand than they need to.
JZ would have been killed by people if they did that.
They repeatedly went with 3 options, NCE seemed to be a hold up, if they then went GIA and diluted that would have been worse than what happened IMO.
I think they know Lovaza is off label for a large amount of sales, I think they know the Marine penetration can only be so much with getting people to switch to Lovaza with Tier 2 for Lovaza and a drug people have been taking that works enough for them to stay on it.
Hiring a large sales force for Marine I think would not have been a good use of dilution.
According to JZ with the force they have they will have seen 70% of cardiologists targeted 4-5 times by end of Q2 so it seems they have the Marine market in cardiologists covered properly so hard to say the sales force is too small for Marine.
The other problem was most large investors expected a drop to 8 on GIA so when going to get new stock sold to investors they likely would have gotten less than 8 and, again, JZ would have been killed over that. If they were diluting that meant GIA to the people buying the new stock which meant selling stock at 8 when price was 12-15, how would that have gone over?
Their approach is a long term one with Anchor the focus of the reward, if they mess up on Anchor launch criticism will be justified, but since the main "product" they have to sell is Anchor and the value of the business will be determined by Anchor(and later REDUCE IT) I need to see Anchor play out before I can criticize management despite the stock price drop.
I can wait the 6 months. It's just a waiting game on Anchor right now.
He is supposed to create shareholder value over the long term and he is taking steps to do that, CEO's and investors spend too much time trying to think short term.
People really need to stop with that, he listed the coming items over 90 days, the NCE a big part of it, they misjudged NCE but that timing changed by FDA. he lists specific things that were, to him, exciting events coming that mostly happened and people kill him for it AND those same people now want him to say something similar. Perhaps he's learned his lesson promise little, deliver much
Small biotech is ripe with speculators and big swings.
When you analyze the ISIS details not much of the move makes sense. It's seems some investors read the headlines only, expect it will slowly drop back down as the traders get out of the trade and the shorts have finished covering.
I don;t know why people keep bringing up CEO's that spoke and the stock still went down. I don;t need an emotional feel good talk from the CEO, just don;t see the need or point, people act like investors are stupid, if the CEO says nice things about his stock(you know the one he owns a ton of shares in, makes his money by being in charge of etc...) that WS will go, hey the CEO says things are great, screw the due diligence we did, the CEO says things are good, yippeeee.
ATPG went from high teens to 6 and the CFO came out and said, its absurd the stock is so low, never seen it so undervalued blah blah and 6 months later bankrupt.
Many companies don't just comment because a stock price is down, most actually will not as they are interested in the facts and no new facts have come up to comment about.
They have an annual meeting next week, discuss the board then, people move on, boards change, reading more into that I don't see.
The biotech's generally have many low stock option incentives as getting a drug to market is a low percentage shot and rewarding management when they do is common. Again there were some insider buys on ATPG...again not meaningful when you consider how many options and thus how many shares management has.
If Joe bought stock tomorrow price would go up 50 cents and next week same spot. he has much to gain by a higher stock price, anyone really think WS will care if he has even more at stake?
They won't, they want sales and a partner and Anchor approval. Buying shares, coming out with rah rah means nothing to the stock price 6 months from now.
Unless he comes out and says talking to 3 companies about a BO what's the point.
There are so many different plans that does not answer the question what tier that is, some plans Tier 3 has a $50 cap so it sounds like tier 3 for Anthem still.
Other Anthem plans do a percentage on tier 3 so really depends on the plan as tier 3 coverage is bad on some plans and not so bad on others. Sounds like AZ plan mentioned tier 3 is $60. My tier 3 is 30% copay so would be around $72 for my Anthem plan.
Tier 2 gets it down to an average around $25 I would think, generally cuts the cost in half.
$25 for Lovaza or $50 for Vascepa equals $300 per year, not chump change to many
Sometimes a CEO cannot do anything for the stock price, there is a thing called timing.
WS does not like small biotech GIA. Nothing JZ can say will change that and thus nothing he can say will boost the stock price.
He's made it pretty clear if they execute (Sales, Anchor, partner) stock price will take care of itself.
Nothing is going on behind the scenes that is driving the price lower. The company will have less than 15 million in sales YTD at end of Q2, sales for Marine cannot sustain the company, nothing can happen on Anchor until October. Many people got in hoping for NCE resolution followed by BO. With the stock down from 15-8 then 5's many people underwater, many people itching to get out, any small negative blurb makes for some more sellers.
In addition you have a half decent percent short interest, not overly large for a small bio but still a factor.
I don't see a large lack of communication.
We know they are looking to partner for Anchor, we know they have an Adcom, we know the Anchor approval date is December 20, we know Marine sales are growing but that Anchor is the key. I think common sense deduces until Adcom there will be no Anchor deal but between Adcom and Launch we could have a deal.
I'm not sure what people want them to say that they think will support the stock price for more than a few hours.
There is no evidence JZ is viewed negatively by BP. BP did not buy because JZ set price at a level that likely includes Yes on NCE and Yes on Anchor. BP set there level on, maybe yes, maybe no.
AMRN is in much better partnership discussion once they have Adcom and approval looks highly likely. So any partner discussions should be preliminary until Adcom, possible they get something done beforehand but if I was BP I'd wait for Adcom, no reason not to.
Unless someone can think of some words that JZ can say that means
1)We have a BP partner
2)Marine Sales are 500 million this year
nothing he can say will effect the stock price. We need concrete news not false promotion, sometimes there is just nothing can be said.
I think there could have been a BO last year with a quick NCE decision, however once they had to launch Marine I didn't see any reason for a BO until 6 months to a year into Anchor as it makes no sense to sell before Anchor is launched. Slight possibility of a BO if NCE is positive and Anchor Adcom clearly shows Anchor will be approved but odds are very high there will be a partnership for Anchor launch-which WS will likely love as they hate the small bio GIA look. I believe that partner will then buy the company 6 months to a year into Anchor launch. I've been thinking that will be the way it plays out since they had to launch marine.
Having a full year in marine and moving towards Tier 2 gives Anchor launch a giant head start. Add to that the large Lovaza off label useage and the ramp up for Anchor with the proper sales force will be enormous-much bigger than if they did not have marine to start.
They should have a full year to get Tier 2 so by Anchor launch expect large tier 2 coverage, a sales force north of 1,000, an experienced partner, much cheaper than Lovaza with insurance coverage for Anchor...that is the ideal..that is why I hold the stock through the initial launch downturn and look towards Anchor.
BO is still the end goal but agree it's not happening until mid-2014 at the earliest.
I can't imagine they could dilute for enough money and shares at $5 something. They will need more cash in 2014 to launch Anchor with the 1000+ more sales reps but until they get a partner and we see what they get for the partnership it's very possible they will never need to raise. Now, today, they are not diluting and the stock price is not reflective of that since it is not decided how they are getting the money for Anchor yet and won't be determined until end of year. So don't see your view on dilution coming, at this time, being accurate.
I think they want to differentiate from Lovaza and they wanted to have a successful trial, they worked with FDA on set up of trials.
People forget the Vascepa results were surprisingly good, better than management was hoping for. They also seem to forget it was focused on Trig lowering.
No atrial fib, no increase in LDL vs. Lovaza so game over on that comparison. But they could not know that in the beginning but the results are easily comparable to Lovaza so the Placebo results are just as effective.
CV Health biomarkers in other area were better with Vascepa as well.
Vascepa got 22% trig and 14% reduction NON-HDL-C with zero side effects.
The endpoint of the Anchor study was TG Reduction and Lovaza was non-HDL-C which it did a 9% improvement(Vascepa 15%).
Lovaza failed to get the indication due to the increase in LDL-C that was considered significant.
Vascepa from baseline had LDL-C reduction as well as meaningful improvements in all areas. Adjusted for Placebo it was even better though LDL-C the adjustment for Placebo actually hurt Vascepa.
So Lovaza would be approved for High Trigs IF LDL-C was not increased. Vascepa actually improved on the main Endpoint in the Lovaza Combo trial, passed with flying colors it's own endpoint and reduced LDL-C.
The atrial fib for Lovaza was not shown until later so had no effect on the denial of Lovaza for Anchor. It was mainly LDL-C increase that caused the failure to get the indication and also why doctors felt comfortable prescribing off label becaue the details of the Lovaza study could be argued LDL-C was not increased as bad as the statistical analysis suggested. The Atrial Fib came later but way past when doctors felt comfortable prescribing.
So Vascepa will take 100% of Anchor market not only because of the LDL and Atrial Fib but because insurance will pay for Vascepa and not Lovaza for that indication. Simple as that. Clearly based on Lovaza scripts doctors feel OK with the side effects but once educated with the partner sales force they will easily switch to Vascepa due to cost and side effects.
Also most of the numbers outside of adjustments from the Placebo were good decreases but studies are designed to compare against Placebos, that's common so they way they report the data is common, the results are good, the results will easily pass muster.
Anchor will be approved, the science is good, the benefit is proven.
The arguments from MSG on SA are poor from a scientific point of view.
It's a 4% decrease compared to placebo which is considered not significant, if the other baselines were only 4% improvement the drug would never have passed, in other words it's such a small change that
1) The effects are negligible
2) A larger sample may show no change or slightly more or less that at 4% you can't say Vascepa lowers HDL but total cholesterol less good cholesterol of 18%
In the article even AF says no competitor for Vascepa as will be limited to a small subset of patients so AF does indeed nail it: no real risk to AMRN and Vascepa.
"ISIS-APOCIIIRx is a potential competitor to Amarin's Vascepa, BUT the need for weekly injections plus the risk that long-term use may lead to safety issues are likely to limit it to use in patients with much more severe disease"
I can't read the very bottom, though that would be a nice skill, but I can play percentages and have a good understanding of trends and technical's where I can put percentages to work in determining when to add. Obviously there is no fool proof system but I don't like to fight trends until I see a reversal of a trend, we're still getting lower lows and lower highs.
I will almost always miss the first leg back up but I have my core position either way and my analysis of the trend is it is still down and then my analysis of potential stock moving news is not until Adcom(barring NCE news) so will continue to wait until trend changes or news is closer.
I also believe worst case scenario the stock would get bought above current market cap so in that way adding more at these levels makes sense, odds are high in the LT you make money. Just not quite ready to pull the trigger myself.
Comparison:
Company 1:
2014 Sales estimate: 115 million (Range 70-177)
2014 Loss per share estimate: -.81
Current Ratio: 6.14
Company 2 :
2014 Sales estimate: 264 million (Range 161-605)
2014 Loss per share estimate: -.60
Current Ratio: 5.71
Company 1 Market Cap(ISIS): 2.82 billion
Company 2 Market Cap(AMRN): 900 million
Either ISIS is way over-valued or AMRN way Under valued or more likely somewhere in between.
I understand ISIS had a large pipeline and AMRN has 1 drug with multiple possible uses but a large pipeline also equals large costs for trials. There is no way ISIS is worth almost 3 times AMRN.
I'd say the BIG difference between the 2 is ISIS ability to partner with BP regularly which, to me, comes down to the whole reason the AMRN stock languishes, WS wants a BP partner, nobody has faith in a small company becoming a big company in Biotech without a partner.
Makes you wonder if AMRN should have looked to partner on day 1 of approval? I think they believe they could get a better deal waiting for Anchor, combo results etc.. as it takes uncertainty off the table, probably correct in that assessment so not sure what they could do differently to have reduced some of the haircut the stock price has taken.
I also think AMRN knows they HAVE TO partner for Anchor or stock price will be even worse. Problem is BP knows this also so will be interesting how many parties they can get involved to maximize the partnership deal. I hope they take the best BP partnership offer and don't hold a high premium and thus go another route.
It's getting there on time to add more, not quite there yet but Market cap is below fire sale price at this point so key is to look away and come back in a few months.
The next 2 weeks will have good scripts, then the first 2 weeks of July have many vacations so will be down seasonally, then the second half of July I will think about adding but may wait until before Adcom.
Will also need to work through the irrational fear of the FED easing off.
If the economy falters FED will continue bond buying yet market sells off on fear economy will be hurt by fed policy change...?
Will get the 10% correction and market will stabilize,
Not sure I see a strong run in AMRN until closer to October Adcom, followed by Anchor partnership with BP which will be the key to whether we see new highs this year.
The ISIS news probably hurt the price today but is an injection, is only in phase 2, is focused on a particular subset, so for now is a non-competitor and as long as it is injection only will be a niche product compared to AMRN and be several years behind.
Omthera went for 443 million so AMRN is only double the market cap with 10 times the potential market.
We are all sick of hearing it..Patience, patience,...enjoy the summer and get ready for fall...one thing we can say is the final 3 months of the year will be very newsworthy...Adcom, Anchor Partner, Anchor FDA Approval, and NCE all likely in that time-frame so before now and October 1 sell some calls, wait to add, do whatever but watching the stock price daily for a LT investment probably not helpful...unfortunately management is executing fine on GIA but WS needs to see Anchor launch details and we have a few months to get to that.
You cannot add in deferred revenue, that's just a product of script sales, if you do that you need to deduct for q2 deferred which will likely be higher but really you just don't add the deferred as its just inventory that would be used first in 2q sales, it's not extra free sales
I believe q1 if you took reported sales from the services and multiplied by 220 you got the 1q sales figure as that accounts for the under reporting automatically, I still come to 9.3 million for q2 using that formula and estimating through end of June.
We will have a better understanding of calculating sales from the weekly reported scripts after q2 as will have higher volume and be more accurate.
A little too conspiracy theorist for me, Anchor will be approved, NCE will be decided, most likely favorably, at some point this year. There are way too many stretches in your theory, circumstantial is probably giving the theory too much credence. Not buying any if it
I get around 9.3 million for 2Q sales, still above 8.2 estimates but nowhere near 13 million.
He just excercised options at a buck something and now holds 10k more shares, could be options were expiring so needed to turn into shares, he did same thing in April and Thero did same thing in May. 1.35 seems to be the price, that 13k won't help cash flow much
I'm onto something only off by 10 total scripts, I think I have the basic formula down here
From my earlier post
Using the refill to prescriptions I get
6/14-1620
6/21-1805
6/28-2044
7/5-2145
7/12-2337
In reality Expect 7/5 down with holiday and 7/12 up but total for 2 weeks about 4482
FYI total script expected #'s with 3% weekly growth on new scripts
6/14-4139
6/21-4400
6/28-4717
7/5-4898
7/12-5172
A few dollars on combo news? It's positive long term, more evidence of AMRN working, adds value to the eventual BO but short term not sure many people that understood the combo news thought it was worth much short term, it is probably worth a few dollars, in a BO but not today.
Anchor has been the play all along. If NCE was decided right away the company would have been bought before any launch, since it was not it did not make any sense for AMRN to partner for Marine, did not make much sense for BP to partner for Marine.
Peak sales of 1.8 billion as one analyst put out today-not one of the bullish analysts) puts BO in 5 billion range.
I'm not sure what delusional world people live in.
If you are running and investment firm or a mutual fund you look at AMRN and see
1)Small biotech-no partner, no pipeline-Those almost always fail
2) Sales at this pace they run out of money in 2014
Those are not stocks they normally invest heavily in.
So you need those things to change and, like many other biotechs the stock price, when it runs, will and can run rapidly, but for now its daytraders and trend is down.
I've stated many times since December looking to add more but need to see the daytrading trend change, have not seen it.
Right now it trades on technical as WS is not interested in force for 2 reasons above.
I have faith management will succeed with Anchor partner and that leads to 500 million plus in 2014 sales, hey could be wrong but I think those odds are pretty high. At that point stock is worth 3 billion so going to 5 for a BO not too big a jump.
They fail with Anchor deal whole other ballgame and whole new analysis of the stock needed.
I have other investments making money, down on AMRN, never do margin, individual stocks I never overextend myself where I panic sell, AMRN is a hold until Anchor launch and then review the details of that and then hold for end of 2014 if deal looks good. WS doesn't get it right much of the time, computer and technical traders control the ST in most stocks, LT it's the bigger investors, once they have reason to get in AMRN the stock will take off, just need to have a long term view.
It's not going to Zero, if they screw the Anchor deal BP would still pay 1-2 billion for the drug. LT almost no downside, ST, still possible downside
Sell some OTM calls or buy some more and sell OTM calls
On NCE? Several dollars in the bag on that approval. It Guarantees no generics even remotely possible until 2020, brings the partnership/BO talks to another level, NCE news would absolutely move this several dollars and the gap up would be easily $1, maybe $2.
It's not comparable to patents and Phase 1 Combo news as all the news out there from AMRN has been positive but positive for the LONG TERM. The stock price is laboring because big investors want concrete near term news, NCE is great long term and short term. Anchor and sales are the other short term catalysts but big sales are tied to Anchor so getting WS interested starts with NCE and then goes with Anchor approval and partnership. Those are the 2 big catalysts, anything that relates to those items will be the real mover of the stocks.
NCE means increased peak sales-BIG!
Anchor means BB sales-BIG!
They are the real stock movers and both will happen by end of year.
No compelling reason to buy is subjective, the stock is at lows it has not seen in awhile so if you a long term investor or want to make gains long term for tax purposes it's a good time to buy, is it a bottom? Might not be but then timing a bottom is hard.
Is the company a good value at current prices(50% below Lovaza BO price)? If you conclude it's a good value ten it's a compelling reason to buy.
If you wait for news to buy it's probably a gap up...What if NCE news comes July? Gap up and you likely missed $2 in profit...now it's a timing game
Odds of sales continuing to increase-almost 100% with refills
Odds of Anchor approval-close to 100%
Odds of partnership for Anchor-Close to 100% just a queston as to how favorable the terms
Odds of NCE approval-Pretty High
Downside catalysts-There may not be substantial news until October, that's pretty much it, so 3 months maximum for shorts before news pushes more institutional investments into AMRN with more concrete news for the to buy in on.
July 2016 is when the generic would be available, it's within a year after that REDUCE IT results could be out, interesting timing for the combo.
Combo results are nice, nothing earth shattering in Phase 1, don't think it moves the stock much. Continued sales increases helps but Anchor approval still the main driver, these other things just help put a bottom in and give us a better base.
Can't know that until it gets there.
For a long term hold you can buy any point in here, in a worst case scenario management screws up bad and dumps the company to BP for similar price as Lovaza was sold which is 50% higher than here.
Short term, need to see some technical improvement and/or some catalysts related to Anchor which may not happen until October leading into Adcom.
Otherwise it should trade how the market trades though it's Marine peak sales alone are probably making it cheap even now
I've been waiting for a point to average down and have not done it yet, if I miss my spot I'm OK with my core position but trading wise not ready to pull the trigger, might not be until late September leading to Adcom. Doesn't mean stock has not bottomed, just no catalyst to take it strongly higher close enough to make a bigger investment for me.
"If Reduce It can't be finished then somebody else with more secure funding can do the same thing later."
I think that's not going to happen, they dosed in 2011 so by Anchor they are 2 years in of a 6 year study and nobody else is remotely close to doing a study.
Having Reduce IT underway was a clear indication that the FDA wants this question put to bed. Many cardiologists and doctors want Reduce IT. AMRN cannot afford to do Reduce It without Anchor and FDA knows that.
The comparison to NCE is misplaced. FDA has been sued for NCE decisions, FDA has had to reverse previous decisions, FDA has created a whole new panel and guidelines for NCE thus NCE is a totally different ball of wax when compared to Reduce IT and Anchor.
The FDA would need to totally, 100% reverse course on Anchor and there is no compelling evidence to do so. Vascepa does what it says it will do with no side effects.
The only argument people make against it is that the FDA would want outcome trial results before approving. Dismissing that is easy when you analyze it and realize they won't get the outcome trial without approval. To say someone else will do it is not reality. That would be way down the line and does the public zero good.
I can't believe there are more than a handful of people that think Anchor won't be approved.
The FDA wants an answer as to cardiac events and fish oil-particularly Pure EPA since JELIS study says it does prevent.
The FDA wanted the REDUCE IT underway for Anchor and they know the study is VERY well designed with top people on REDUCE IT. It will be a definitive answer.
If they did deny Anchor, AMRN will likely not be able to afford REDUCE IT and FDA doesn't get the results it wants to see. Nobody else is close to starting a similar study, FDA has to approve Anchor, they really want to approve Anchor, they have Zero reasons to not approve Anchor and if they want a final answer from REDUCE IT they will approve Anchor..
There is no negative, will be unanimous vote for approval, simple as that, the red herring of REDUCE I outcome before Anchor results is ridiculous.
There is ZERO requirement for this, they will let doctors decide if it is worthwhile to give before REDUCE IT results.
With no side effects FDA has no reason to step in even with any questions on reducing cardiac events since it may reduce cardiac events(only study ever done says it does and zero studies says it doesn't) as Anchor approval and REDUCE IT results are NOT related.
FDA also knows Lovaza is prescribed heavily in Anchor population and has bad side effects so they not only WILL approve but WANT TO APPROVE Vascepa to avoid the Lovaza off label prescriptions which are not safe.
I'm beginning to believe NCE will be related to Adcom since there was another delay in June I think NCE will be discussed at Adcom which is why I think it is important.
It will also put to rest any doubts of them not being approved for Anchor. There should be little doubt anyways but what doubt there is will be put to rest.
Less than 4 months to Adcom and less then 6 months to Anchor approval...tick, tick, tick
If Anchor partnership does not happen for whatever reason and no BO then they will run out of money in 2014 with Anchor launch.
The expectation is a partnership will give an influx of cash or reduce expenses greatly thus dilution is not needed but they will need money to launch Anchor properly. The sales force will increase 5 times what it is now.
Since they clearly stated they are not launching alone in Anchor you would expect they could avoid needing to raise money with a partnership but not knowing the interest and details of the partnership cannot say for sure.
If they do raise money for Anchor launch it is also hard to tell if it would be conventional, convertible, straight dilution etc..
What rumors are you referring to?
The PDUFA is 12-20-13.
Also, no PR on Adcom means no date set yet so the December you recall was likely speculation on a board or you are confusing it with PDUFA date
PRESS RELEASE EXCERPT
The application will be subject to a standard review and has been assigned a Prescription Drug User Fee Act (PDUFA) date of December 20, 2013. The PDUFA date is the target date for the FDA to complete its review of the sNDA.
Adcom reviews safety and efficacy, would be a pretty easy Adcom, The reason they would hold one is guidelines recommend there be one in this instance.
They can always ignore the guidelines because it is so obvious in this case but FDA is rather conservative so since it is recommended they have an Adcom they probably will. The guidelines were put in place to have something to follow, it is rare a drug such as Vascepa comes along, no side effects, meets all endpoints so guidelines were not really written with Vasepa in mind, it just happens to be the first fish oil drug in High trig thus automatically it is recommended to have an Adcom.